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Roundtable/FDA: The ABC’s of EFS: Discussions of Early Feasibility Studies in EP with the FDA, Investigators and Industry
Description
The proposed session is a follow on to Session EN-613 at HRS 2022: "Roundtable/FDA: Early Feasibility Studies in the US: Discussion with FDA, Industry and Investigators". The 2022 session included significant participation including Duy Nguyen, George Van Hare (HRS and FDA roles), Nadim Yared, Devi Nair, Paul Wang, Brad Knight, Chris Ellis, and Vivek Reddy amongst others and created terriffic discussion we hope of significant interest to the HRS Community as an introduction to the effort to bring more EFS work back to the US.
For 2023 we hope to move this forward with a more practical focus. We will propose speakers to discuss actual experience wth US EFS in EP, as well as introduction of available "toolkit" itmes such as Master Clinical Trial Agreement and EFS focused Patient Consent documents. Focus will be on shorter talks and more extensive discussion with the above leaders as well as FDA representatives and Industry partners. We would expect many of the above listed participants to participate in a panel discussion after the talks.
Learning Objectives
  • Describe the key details of success in the process of successful EFS studies that have been performed in the U.S.
  • Outline how to develop EFS programs including regulatory and IRB approval, budgeting and contracting, and site start-up.
  • Discuss the EFS process, its challenges, benefits, and key aspects related to success.
Session Chair(s)
J. Peter Weiss, MD, MSci
Emily Zeitler, MD, MHS
Presentations
Early Feasibility Studies: Why in the US and Why Not?
Presenter(s): Vivek Y. Reddy, MD

EFS and the FDA: Key Aspects of Facilitating US Studies
Presenter(s): Andrew Farb, MD

The Northwestern Experience: A Model for Success
Presenter(s): Anna Huskin

Perspective on the EFS Ecosystem and Early Device Development in the US
Presenter(s): Avi Fischer

Conformal Medical: Why we chose the US for EFS
Presenter(s): Aaron Kaplan, MD
Disclosures
Vivek Reddy:
  • Abbott (Honoraria/Speaking/Consulting Fee)
  • Acutus Medical Inc (Stock Options – Publicly Traded)
  • Affera, Inc. (Stocks – Privately Held)
  • Aquaheart (Stock Options – Privately Held (including start-up companies))
  • Autonomix (Stock Options – Privately Held (including start-up companies))
  • Axon (Stock Options – Privately Held (including start-up companies))
  • BackBeat (Stock Options – Privately Held (including start-up companies))
  • Biosig Technologies, Inc. (Stock Options – Publicly Traded)
  • Circa Scientific (Stock Options – Privately Held (including start-up companies))
  • Corvia Medical (Stock Options – Privately Held (including start-up companies))
  • EpiEP (Stocks – Privately Held)
  • CardioNXT (Stocks – Privately Held)
  • AFTX (Stock Options – Privately Held (including start-up companies))
  • Farapulse (Stock Options – Privately Held (including start-up companies))
  • FIRE1 (Stock Options – Privately Held (including start-up companies))
  • Luxcath (Stock Options – Privately Held (including start-up companies))
  • Manual Surgical Sciences (Stocks – Privately Held)
  • Medlumics (Stock Options – Privately Held (including start-up companies))
  • NewPace Ltd (Stock Options – Privately Held (including start-up companies))
  • Surecor (Stock Options – Privately Held (including start-up companies))
  • VytronUS, Inc. (Stock Options – Privately Held (including start-up companies))
  • Valcare (Stock Options – Privately Held (including start-up companies))
  • VIZARA (Stocks – Privately Held)
  • CardiaCare (Stock Options – Privately Held (including start-up companies))
  • Ablacon, Inc. (Stock Options – Privately Held (including start-up companies))
  • Dinova (Stock Options – Privately Held (including start-up companies))
  • Kardium (Stock Options – Privately Held (including start-up companies))
  • HRT (Stock Options – Privately Held (including start-up companies))
  • Intershunt (Stock Options – Privately Held (including start-up companies))
  • AtaCor Medical Inc (Stock Options – Privately Held (including start-up companies))
  • Sirona Medical Technologies, Inc (Stock Options – Privately Held (including start-up companies))
  • CoreMap (Honoraria/Speaking/Consulting Fee)
  • Corisma Inc (Stock Options – Privately Held (including start-up companies))
  • Restore Medical (Stocks – Privately Held)
Andrew Farb: Nothing Relevant to Disclose
Anna Huskin: Nothing Relevant to Disclose
Aaron Kaplan:
  • Conformal Medical, Inc (Intellectual Property Rights)
  • Boston Scientific (Research (Contracted Grants for PIs and Named Investigators only))
  • Medtronic,Inc. (Research (Contracted Grants for PIs and Named Investigators only))
  • Edwards Lifesciences (Research (Contracted Grants for PIs and Named Investigators only))
Avi Fischer:
  • Orchestra Biomed (Salary from Employment)


To view all Heart Rhythm 2023 Faculty Disclosures, please click here.
Education Framework
Tachyarrhythmias
Supraventricular
AFib and Flutter
Catheter Ablation - AF
General Concepts
Communication Skills and Shared Decision Making
LA Appendage Management
n/a – non-clinical content
Summary
Availability: On-Demand
Cost: FREE
Credit Offered:
No Credit Offered
Recommended
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